VirtualBackroom.ai Help Guide

Start here

This guide explains what VirtualBackroom.ai does, how to get in, how the screens are organised and how to complete the common tasks. It is written for two readers at once: people, and AI agents that operate a web browser on a person's behalf. Everything in it describes the product as it is today, with the exact labels you will see on screen.

In one paragraph. VirtualBackroom.ai is an advisory and training platform for medical-device quality and regulatory teams, with tools that also serve general supplier quality (ISO 9001, IATF 16949, AS9100D). It combines deterministic tools (QMSR exposure scoring, acceptance sampling, capability and Gage R&R maths), AI tools (a multi-model council, audit simulations, gap analysis, AI-assisted FMEA / 8D / PPAP / APQP) and record-keeping tools (CAPA with dual-control approval, Complaint Log, Management Review, Process Validation, Supplier Quality). Every AI output is logged to an audit trail and labelled as a draft for human review.

• It is not a certified electronic QMS, it does not replace your procedures or your regulatory counsel, and it never files anything with a regulator.
• Deterministic results (exposure scores, sampling plans, Cp/Cpk, Gage R&R) are computed by code, not by a model.
• The full intended-use statement is at /ai-boundaries; security posture at /security.

Rules for AI agents

These rules apply to any automated agent (computer-use model, browser agent, RPA script) operating the product. They mirror what the server enforces and what the account owner is responsible for.

1. Read /llms.txt first, then this guide in plain text at /help/guide.md (structured: /help/guide.json). Re-read it when a screen does not match what you expected; the guide is versioned (see the version line at the top).
2. Operate the product the way a person would: through the browser, using the visible labels quoted in bold in this guide. Do not try to call internal API endpoints that this guide does not document, and do not attempt to bypass sign-in, plan gating or approval steps.
3. Only act inside an account whose owner has asked you to. Sign-in is Google only; the owner must complete the Google pop-up themselves or hand you an already signed-in browser session. Never create, guess or share credentials.
4. Never type patient data, protected health information (PHI), personal data about third parties or confidential trade secrets into any field. The product is advisory; records you create may be reviewed by auditors, so enter only what the owner gave you.
5. Do not invent regulated content. If a form asks for a root cause, a measurement, a complaint summary or a management-review decision and the owner did not supply it, stop and ask. AI drafts inside the product are labelled as drafts; a human must review them before they are treated as a record.
6. Dual control is enforced by the server: the person who created or owns a CAPA, FMEA or validation protocol can never approve it. If you are asked to approve something you created, the request will fail (HTTP 403) by design. Hand the approval to a different authorised user.
7. Long-running actions exist: the AI Council streams for one to three minutes; exposure narratives are generated in the background and appear after a refresh. Wait for completion indicators instead of re-submitting, which would spend the owner's AI quota again.
8. Being redirected to /login means the session has expired; being shown a page that says Upgrade means the feature needs a higher plan (see Plans); HTTP 429 means a rate limit was hit, so pause before retrying.
9. Destructive actions (delete supplier, delete complaint, Permanently delete my account) require explicit confirmation from the account owner each time. Do not perform them on your own initiative.

Getting in: public pages, sign-in and plans

Public pages (no sign-in)

• / landing page; /for/ pages for each professional role; /subscription/pricing plans.
• /exposure-check/ the free QMSR Exposure Check; /demo/qms-os-tour/ the self-service product tour.
• /about (includes the changelog), /faq, /security, /ai-boundaries, /methodology, /privacy, /terms, and this guide at /help.
• /pack the QMSR Knowledge Pack, a one-time purchase of Markdown reference files that needs no account (see Knowledge Pack below); the free sample is at /pack/sample.

Sign in

1. Open /login.
2. Click Sign in with Google. A Google pop-up window opens; complete it there. Continue with Microsoft and Continue with Apple appear only when the operator has enabled them.
3. On success you land on /dashboard. There is no username-and-password form; /register redirects back to the sign-in page.

When self-serve sign-up is closed, the sign-in page shows Request an Invitation: enter Your Name, Work Email, Organization and Why do you need access?, then Submit Request. An administrator reviews the request and e-mails an invitation.

Sign out from the account menu (Logout) or by opening /logout.

Plans

Tier badges in the feature reference below use the same names. A page that needs a higher plan shows an upgrade page instead of the tool; upgrades are self-serve at /subscription/pricing (Upgrade to Pro / Upgrade to Premium open a Stripe checkout).

Settings

• /core/settings: change Display Name, toggle Email notifications for audit updates, Regulatory change alerts and Weekly compliance digest, then Save Changes.
• Pro Mode / Simple Mode switches the menu between the full tool set and a reduced one. Restart onboarding tour replays the guided tour.
• Download my data (/core/settings/export-data) returns your records as a file.
• Delete account… asks you to type DELETE and click Permanently delete my account. This is irreversible and also removes linked sign-in providers.

Finding your way around

After sign-in the top navigation bar contains, from left to right:

• Direct links: Audit Coach, Gap Analysis, Citation Check (/regulatory-browser/citation), Issues (/issues/) and Council.
• Compliance menu: FDA Warning Letters, CAPA Management, Approval Queue (/approvals), AI Audit Trail (/ai-audit/), Compliance Exposure, QMSR Transition (/qmsr/) and Self-Assessment (/qmsr/qms-assessment).
• Supplier Quality menu (Premium): Suppliers & Audit Prep, COPQ Analyzer.
• Tools menu: Mind Map Generator, Simulations, Regulatory Assistant, Regulatory Browser (/regulatory-browser/), FMEA, 8D Investigation Co-Pilot, PPAP Submission Review, APQP Phase-Gate Tracker, Quality Statistics, Management Review, Process Validation, Complaint Log, Vendor Validation Pack.
• Live News, Regulatory Alerts, Upgrade, and the account menu with Settings and Logout.

• The dashboard at /dashboard greets you by name and offers Run QMSR Readiness Check, Audit Coach and Start New Audit, plus recent regulatory news.
• The footer of every page links AI Boundaries, About, FAQ and the role pages, and has a Report Issue button that opens a form in a dialog.
• Signed-in users see a round button labelled Open help assistant in the corner: an AI chat about the product itself. Like every AI output here, its answers are advisory.
• Theme: the moon / sun button in the navigation bar switches light and dark mode; the choice is remembered in the browser.
• Keyboard shortcuts: press ? for the list. g c opens the Council, g w the warning letters, g f FMEA, g d the dashboard, / focuses search and Esc closes any open dialog.

Feature reference: what each tool does and how to use it

Each entry gives the plan the tool needs, its address, what it does and the exact clicks. "Not this" lines state the boundaries so nobody over-promises on the product's behalf.

QMSR Exposure Check — Free plan — /exposure-check

A deterministic read on where a device company is exposed under the FDA QMSR, with a per-area report. No account needed.

1. Open /exposure-check/. No sign-in and no upload is needed.
2. Fill in Company name (optional), Highest device class, Regulatory pathways, Markets and Key processes. Tick We are ISO 13485 certified and We have an open FDA Form 483 or Warning Letter only if they are true.
3. Click See my exposure preview. The preview page ranks the areas where the profile is most exposed under the FDA QMSR.
4. To get the full per-area report, enter Your name, Company and Work email on the preview page and click Unlock my full report. Start over clears the profile.

• Not this: It is a deterministic self-assessment from the answers given; it is not an audit finding and does not read any of your documents.

Self-service product demo — Free plan — /demo/qms-os-tour/

A guided tour of the QMS OS with sample data. Nothing to install, nothing to upload.

1. Open /demo/qms-os-tour/. The tour is public and uses demo data only.
2. Follow the on-screen steps; nothing you do in the demo touches a real account.

• Not this: The demo does not create an account and does not keep anything you type.

Standards Library — Free plan — /standards-library

Browse every standard the platform can cite, with the clause formats the citation validator accepts.

1. Open /standards-library.
2. Each card shows a standard the platform can cite and the clause formats it recognises (for example ISO 13485:2016 §7.3.2). Use these formats when you ask the Council or the regulatory assistant a clause-specific question.
3. Open AI Council jumps to Council Mode with the library at hand.

• Not this: The library lists citable formats; it does not reproduce the full text of paid standards.

Warning Letter Insights — Free plan — /qmsr/warning-letters

Every FDA medical-device warning letter, fetched daily, with deficiencies mapped to QMSR and ISO 13485 clauses. Browser on Free; bulk analysis on Pro.

1. Open /qmsr/warning-letters (sign-in required; browsing is free).
2. Filter and open letters. Each analysed letter shows its deficiencies mapped to FDA QMSR and ISO 13485 clauses; the corpus is refreshed daily from FDA.
3. Run Live AI Analysis analyses letters in bulk and needs a Pro plan.

• Not this: Letters are FDA public records; the platform adds the clause mapping, it does not edit the letters.

Regulatory radar & alerts — Free plan — /regulatory-alerts

A feed of regulatory changes relevant to device and supplier quality programs. Browse on Free; custom alerts on Pro.

1. Open /regulatory-alerts for the alert feed and /regulatory-news for live news.
2. Free accounts can browse. Pro accounts get the full news feed and custom alerts; e-mail preferences live in /core/settings under Regulatory change alerts and Weekly compliance digest.

• Not this: The feed is informational; it is not legal advice and does not track your own submissions.

Audit Coach simulations — Free plan — /simulations/

Practice FDA-style and ISO inspections against an AI investigator, with scored debriefs and weakness reports. Three simulations a month on Free; unlimited on Pro.

1. Open /simulations/.
2. For a fast start, pick a Regulatory Standard and Difficulty and click Quick Start Audit. For a configured run, click Custom Setup and complete the form, then Create Simulation.
3. Answer the AI investigator's questions in turn. Use Continue to resume a simulation and View Results to read the scored debrief and weakness report.
4. Scenario-based QMSR practice with a printable action checklist is at /qmsr/audit-scenarios: choose a scenario and click Start Simulation; finished runs offer Export to PDF.

• Not this: Free accounts get 3 simulations a month; Pro is unlimited.
• Not this: A simulation is training. Its score is not an audit result and is not shared with any regulator.

Compliance Exposure dashboard — Free plan — /compliance-exposure

Inherent vs. residual exposure for your company, re-scored as your posture answers change. CAPA hand-off and PDF export on Pro.

1. Open /compliance-exposure/.
2. Click Add Company Profile and complete Company name, Device class, ISO 13485 certified, Regulatory pathways, Markets, Key processes, Open FDA Form 483 or Warning Letter and Notes.
3. Click Run Exposure Assessment on the profile, then View the assessment.
4. Each row shows an inherent score (what the product and market imply) and a residual score (after the stated posture), with the clause citations behind it. Export PDF saves the ranking.
5. Create CAPA on a row opens a DRAFT CAPA with the row's citation and both scores recorded as provenance (Pro plan). Pro and Premium assessments also get an AI narrative that is generated in the background; click Refresh after a minute or two.

• Not this: Scores come from a deterministic engine over the enforcement corpus and your answers; the AI narrative explains the rows and never changes them.

Regulatory assistant — Free plan — /regulatory-assistant/

Cited answers to regulatory questions, each logged to the AI audit trail for later review. Metered on Free; unlimited on Pro.

1. Open /regulatory-assistant/ and click New Conversation.
2. Give it a Conversation Title, choose the Regulatory Standard and Industry Context, then click Start Conversation.
3. Type your question and send it. Answers carry citations in the recognised clause formats and every exchange is written to the AI audit trail at /ai-audit/.

• Not this: Free accounts have about 5 AI regulatory scans a month across the AI tools; Pro removes the cap.
• Not this: Answers are drafts for qualified human review, not regulatory advice.

FMEA worksheet — Free plan — /fmea/

ISO 14971-aligned FMEA with AI-suggested failure modes, a colour-coded RPN matrix, CAPA cross-links and PDF/Excel export. Three FMEAs on Free; unlimited on Pro.

1. Open /fmea/ and click Create New FMEA.
2. Complete Name, Description, Device Class, FMEA Type (design, process, use or ISO 14971 risk), Applicable Standards, Owner and optional Team members, then click Create FMEA.
3. In the worksheet add rows (function, failure mode, effects, causes, controls) with severity, occurrence and detection; the RPN matrix recolours as you go. AI-suggested failure modes come from a three-model council and must be accepted, edited or rejected by you.
4. PDF and Excel export the worksheet; the history view lists every change.

• Not this: Free accounts can keep 3 FMEAs with up to 20 items each; Pro is unlimited.
• Not this: AI suggestions never enter the worksheet until a person accepts them.

Regulatory mind maps — Free plan — /mindmap

Visual maps of how regulations, standards and QMS processes connect.

1. Open /mindmap.
2. Choose an input tab: Text Input, Scribe Notes (paste audit or inspection notes; optionally tick the structured-summary option) or From URL.
3. Pick a model under Select AI Model and click Generate Mind Map. Download SVG saves the result.

• Not this: Mind maps are visual summaries for study and planning; they are not controlled documents.

QMSR Gap Analysis — Pro plan — /qmsr/gap-analysis

Upload procedures across 28 QMS document types and get a readiness score, missing clauses, and a board-ready PDF. Overview depth on Free; full analysis on Pro.

1. Open /qmsr/gap-analysis (Pro plan).
2. Upload your procedures one at a time or with Upload Entire Folder, choosing the document type for each (28 QMS document types are supported). Uploads are virus-scanned and PII-sanitised.
3. Click Analyze All. When a document finishes, View Details & Action Items lists the clauses with no covering text and suggested remediation.
4. Generate CAPA (or Create CAPA on a specific gap) raises a DRAFT CAPA pre-filled from the gap. Export PDF produces the readiness report.

• Not this: The readiness score is advisory and depends on what was uploaded; it is not a certification assessment and no document leaves the platform.

Council Mode — Pro plan — /council

Ask one regulatory question to a council of models from OpenAI, Anthropic, Google and Perplexity; compare their cited answers with a consensus score and per-citation verified/unverified flags.

1. Open /council (Pro plan).
2. Type the Question and, if useful, Context (optional). The Standards Library button shows the clause formats the council can cite.
3. Click Consult 12-Model Council. Answers from the OpenAI, Anthropic, Google and Perplexity models stream in side by side; this takes one to three minutes. Cancel stops the run.
4. Read the consensus score and the per-citation flags: each citation is marked verified when it matches a recognised clause format and unverified when it does not. Treat the whole result as a draft for your review.

• Not this: The validation layer annotates citations; it does not remove or rewrite model answers, and the platform never presents a council answer as a final regulatory position.

CAPA management — Pro plan — /qmsr/my-capas

Open, investigate and close corrective actions with a hash-chained history, dual-control approvals, and links from the FMEA line, complaint, deviation, 8D case or exposure row that raised them.

1. CAPAs are raised from a source record rather than from a blank form: Generate CAPA / Create CAPA in Gap Analysis, Create CAPA on a Compliance Exposure row, Promote to CAPA on a Management Review output, a validation deviation, an 8D case or a supplier audit finding.
2. Open /qmsr/my-capas (Pro plan). The tabs All, Draft, Open, In Progress, Pending Approval and Closed filter by status.
3. Click Edit to complete Description, Affected Regulation, Severity, Root Cause, Proposed Actions, Responsible Party and Due Date, then Save Changes. Audit Trail shows the hash-chained history of every change.
4. Closure is dual-controlled: a different authorised user opens /approvals, clicks Review on the CAPA and chooses Approve & Close or Reject. The author cannot approve their own CAPA.

• Not this: There is no effectiveness-check stage in the workflow; record effectiveness evidence in the CAPA text or in a follow-up record.
• Not this: The platform does not submit CAPAs to any regulator or notified body.

Vendor Validation Pack — Pro plan — /validation-pack/

A versioned, date-stamped vendor pack (intended use, traceability matrix, Part 11 capability statement) for validating this software under ISO 13485:2016 §4.1.6.

1. Open /validation-pack/ (Pro plan).
2. The pack is versioned and date-stamped: intended use, out-of-scope statement, requirements-to-feature traceability, a 21 CFR Part 11 capability statement, change-control history and a suggested CSA / GAMP 5 assurance approach.
3. Click Print / save as PDF to file it with your supplier evaluation of this software (ISO 13485:2016 §4.1.6).

• Not this: The pack supports your validation of this software; it is not a claim that your QMS is validated.

Management Review — Premium plan — /management-review/

Builds the ISO 13485:2016 §5.6 review record from data already in the platform and flags every required input that is still unaddressed. Never fabricates a number.

1. Open /management-review/ (Premium plan) and click New review.
2. Enter Title, Period start, Period end, Meeting date and Facilitator, then Create review.
3. On the review page the ISO 13485:2016 §5.6.2 inputs are compiled point-in-time from CAPA, audit, FMEA, complaint and regulatory-change records already in the platform. Inputs with no real data are flagged, never invented; add a Reviewer summary / notes for each and click Save.
4. Click Mark review held (locks inputs) on the meeting day, record decisions under Add output (type, severity, text), use Promote to CAPA where an output needs corrective action, then Close review. Export PDF produces the record.

• Not this: Inputs lock when the review is held; reopen is not available, so hold the review only when the inputs are final.

Process Validation — Premium plan — /process-validation/

IQ / OQ / PQ / PPQ / TMV protocol records with controlled status transitions.

1. Open /process-validation/ (Premium plan) and click New protocol.
2. Enter Title, Validation type (IQ, OQ, PQ, PPQ or TMV), Process / equipment scope, Description / objective and Revalidation interval (months), then Create protocol.
3. While the protocol is in DRAFT, add stages and acceptance criteria. Criteria lock once the protocol leaves DRAFT.
4. Gate 1: a different authorised user approves the protocol to execute. Record results per stage (a saved Quality Statistics study can be attached as evidence), log deviations, then mark it executed. Gate 2: a different user approves the executed protocol. The status flips to revalidation due when the interval lapses.

• Not this: Deviations can be promoted to DRAFT CAPAs; they are never recorded as audit findings.

Quality Statistics — Premium plan — /quality-statistics/

Acceptance sampling (ANSI/ASQ Z1.4), process capability (Cp/Cpk/Pp/Ppk) and Gage R&R computed by a deterministic engine, with optional labelled AI interpretation.

1. Open /quality-statistics/ (Premium plan).
2. New sampling plan: enter Lot size, General inspection level and AQL (% defective), click Compute plan (ANSI/ASQ Z1.4 single sampling).
3. New capability study: enter Upper spec limit (USL), Lower spec limit (LSL) and either summary statistics (Mean, σ within, σ overall) or Subgroups (one per line), click Compute indices (Cp, Cpk, Pp, Ppk per the AIAG SPC manual).
4. New Gage R&R: choose Operators, Parts and Trials, paste the Measurement grid, click Compute Gage R&R (AIAG MSA method).
5. Results are saved under Saved studies and can be attached to a validation protocol stage.

• Not this: All numbers come from a deterministic engine. Any AI interpretation is labelled as such and never alters a result.

Supplier Quality bundle — Premium plan — /supplier-quality/

Supplier audit prep checklists with a finding workflow, weighted supplier scorecards, and a cost-of-poor-quality analyzer.

1. Open /supplier-quality/ (Premium plan).
2. Click Add Supplier and enter Supplier name, Scope of supply, Risk class, Contact email, Applicable standards and Notes.
3. Open a supplier. Create Checklist builds an audit-prep checklist (tick AI-generate items to draft items from the council); findings on a checklist can be promoted to CAPAs. Save a scorecard per period with weights and 0-100 scores for quality, delivery, cost, responsiveness and regulatory performance.
4. Open COPQ Analyzer (/supplier-quality/copq) to log internal, external, appraisal and prevention cost entries from your own figures.

• Not this: Scorecards and COPQ use only the numbers you enter; the platform does not pull supplier data from outside.

8D Co-Pilot — Premium plan — /8d/

Disciplined D0–D8 problem solving following AIAG CQI-20, with AI drafting each discipline for your review.

1. Open /8d/ (Premium plan) and click New 8D Case.
2. Enter Title and Initial problem statement, then Create Case.
3. Work through D1 to D8 in the AIAG CQI-20 structure. Each discipline can be AI-drafted for you to verify and edit; the case can spawn a CAPA when containment or corrective action needs one.

• Not this: Drafts are suggestions; the team keeps the pen on the final text.

PPAP — Premium plan — /ppap/

Production Part Approval packages tracked element by element.

1. Open /ppap/ (Premium plan) and click New Submission.
2. Enter Part Number, Part Name, Supplier and PPAP Level, then Create Submission.
3. Track each of the 18 PPAP elements with its status; each element offers an AI review you can accept or ignore.

• Not this: The tracker records your submission status; it does not exchange data with a customer portal.

APQP — Premium plan — /apqp/

Advanced Product Quality Planning phases and deliverables tracked to launch.

1. Open /apqp/ (Premium plan) and click New Project.
2. Enter Project Name, Customer, Program / Part Code and Description, then Create Project.
3. Track deliverables through the five APQP phases and their gates.

• Not this: Gate status is set by your team; the platform does not approve gates on its own.

Complaint Log — Premium plan — /complaints/

An internal complaint log with MDR reportability screening and a reporting-clock countdown. Manual entry only; it is not an external intake portal and does not submit reports to FDA.

1. Open /complaints/ (Premium plan) and click New complaint.
2. Enter Date received, Product / device, UDI / lot / model, Complaint summary, Severity and Status; answer the reportability questions and give the Date you became aware (starts the 30-day clock). Record the Reportability rationale and, once filed with FDA by your own process, the MDR submitted to FDA on date.
3. Use Linked CAPA (optional) to connect the complaint to an existing CAPA. Edit and Delete are on the list page.
4. Recorded complaints feed the feedback and complaint-handling inputs of the next Management Review automatically.

• Not this: This is an internal log with manual entry only. There is no external intake portal and the platform never submits a report to FDA or any regulator.

Multi-Standard Gap Analysis — Premium plan — /premium/multi-standard-gap-analysis

Assess one QMS against ISO 13485, ISO 9001, IATF 16949, AS9100D and the FDA QMSR in a single pass.

1. Open /premium/multi-standard-gap-analysis (Premium plan).
2. Choose a Document already uploaded in Gap Analysis and tick the Standards to assess against (ISO 13485, ISO 9001, IATF 16949, AS9100D, FDA QMSR), then click Run Multi-Standard Analysis.
3. Export PDF report saves the cross-standard result.

• Not this: Each standard is assessed from the same document text; the output is advisory.

Recall Effectiveness planner — Premium plan — /premium/recall-planner

Plan recall effectiveness checks by level before you ever need one.

1. Open /premium/recall-planner (Premium plan).
2. Enter Product name, UDI / Lot / Model, Recall Class (21 CFR 7.3(m)), Distribution Scope, Target Effectiveness %, Incident Summary and Health Hazard Evaluation (21 CFR 7.41), then Generate Recall Plan.
3. Open a saved plan to review the effectiveness-check level and the plan sections; a plan can spawn a CAPA.

• Not this: Planning only. The platform does not notify FDA, distributors or customers.

Knowledge Pack: reference files, bought once, no account

The QMSR Knowledge Pack at /pack is a product separate from the plans above: a dated edition of Markdown reference files on 21 CFR Part 820 as it reads now (the QMSR), FDA device inspections, 21 CFR Part 11 and EU Annex 11, and the regulatory map for twelve jurisdictions, with front matter and citations on every page so it opens in Notion, Obsidian, Git or an AI assistant. It is sold per person, once; the edition, page count, price and refund terms are stated on the page itself. It is not a subscription, it does not change after purchase, and it contains no text of ISO 13485 or any other standard (clause numbers and titles only).

1. Open /pack. No sign-in is involved anywhere in the purchase.
2. Click Download the free sample to get six pages under the same licence terms. Four of them (the reference pages) can also be read on the site without downloading anything: they are listed under See it on the pack page, and /llms.txt lists their addresses.
3. Click Buy the pack; a Stripe card checkout opens. The button reads Checkout opens soon while the store is closed, in which case email the support address shown on the page.
4. After payment the confirmation page lists the three downloads (Markdown bundle, Notion edition, single file) with checksums, and the same links are emailed to the purchase address. Links stay valid for 30 days.
5. Lost the links? Open /pack/links and enter the purchase email; a fresh set is sent (the page never reveals whether an address bought the pack).

Conventions the product enforces

• Dual control. CAPA closure, FMEA review and both validation-protocol gates must be approved by a different authorised user than the author; approvals are scoped to your organisation. The server returns HTTP 403 when the author tries. The queue is at /approvals.
• Status machines. CAPA: Draft, Open, In Progress, Pending Approval, Closed. Management Review: DRAFT, HELD (inputs locked), CLOSED. Validation protocol: DRAFT, approved to execute, executed, approved, revalidation due. Statuses only move through their defined gates.
• Tamper evidence. CAPA history is hash-chained; FMEA keeps an append-only history; every AI call is written to the AI audit trail at /ai-audit/ with model, time and purpose.
• Honest emptiness. Where data does not exist (a Management Review input, an exposure narrative, a trust statistic) the product shows that it is missing rather than inventing a value.
• Citations. Clause citations follow the formats in the Standards Library. The FDA QMSR is cited at the Part level (21 CFR Part 820); withdrawn subsection numbers are never presented as current requirements.
• Metering and limits. AI calls count against the plan's monthly quota; some actions are rate-limited (HTTP 429). Uploads are virus-scanned and PII-sanitised before analysis.
• Time. Records are stored in UTC and displayed in US Central time.
• Forms. Every form carries a CSRF token and must be submitted from the page itself. Programmatic access is documented separately at /api/docs.

Troubleshooting

Glossary

• QMSR — FDA Quality Management System Regulation, 21 CFR Part 820, which incorporates ISO 13485:2016 by reference.
• CAPA — Corrective and Preventive Action record. FMEA — Failure Mode and Effects Analysis (design, process, use, or ISO 14971 risk).
• 8D — eight-discipline problem-solving method (AIAG CQI-20). PPAP — Production Part Approval Process. APQP — Advanced Product Quality Planning.
• MDR — Medical Device Reporting (FDA adverse-event reporting). COPQ — cost of poor quality.
• IQ / OQ / PQ / PPQ / TMV — installation, operational, performance and process-performance qualification, and test-method validation.
• Cp / Cpk / Pp / Ppk — process capability and performance indices. Gage R&R — measurement-system repeatability and reproducibility.
• Dual control — a second authorised person must approve; the author cannot. ALCOA+ — data-integrity attributes (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available).

More help

• /faq answers the common product and billing questions; /about carries the changelog.
• The footer Report Issue button sends a report with the page address attached.
• Security questions: see /security. Data handling: /privacy and /dpa.